AIR (Artificial Implant for Medial Meniscus Replacement) Study

Osteo Arthritis Knee Clinical Trial

— AIR  

Official title:

Treatment of Medial Knee Joint Pain With the Trammpolin® Meniscus Prosthesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03696836
• Other study ID #: AM-001
• Status: Terminated
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: ATRO Medical B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The AIR Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® meniscus prosthesis system.

Description:

The Trammpolin® meniscus prosthesis is intended to replace the native medial meniscus to provide pain relief in the medial compartment of the knee joint, when this is caused by medial partial meniscectomy.

Patients who meet the inclusion/exclusion criteria and who are implanted with the Trammpolin® meniscus prosthesis will be followed for 2 years. The patient reported outcome measures for knee pain and function, and knee clinical condition by MRI and X-ray is assessed post-operative compared to pre-operative.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 1, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Has medial compartment joint pain with > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI

2. Has a KOOS Pain of = 75 (100 being no pain and the highest attainable score)

3. Is between age 30 and 65 years (inclusive) at the time of screening

4. Has neutral alignment ± 5° of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint, as confirmed by X-ray

5. Is willing to be implanted with the Trammpolin® meniscus prosthesis.

6. Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI's

7. Is able and willing to understand and sign the study Informed Consent Form

8. Is able to read and understand the national language of the country in which the relevant clinical site is located

Exclusion Criteria:

1. Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy

2. Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a Trammpolin® meniscus prosthesis (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)

3. Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the lateral compartment

4. Has a varus or valgus knee deformity of > 5° requiring a tibial or femoral osteotomy

5. Has a varus alignment that is not passively correctable

6. Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL)

7. Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment

8. Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment.

9. Compared to a normal knee, has obvious radiological evidence of medial femoral squaring, anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface

10. Had an ACL reconstruction performed < 9 months prior to surgery

11. Has a BMI > 32.5 at the time of screening

12. Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis

13. Has a knee flexion contracture > 10°

14. Has flexion < 90°

15. Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)

16. Has insufficiency fractures or avascular necrosis of the medial compartment

17. Has an active infection or tumor (local or systemic)

18. Has any type of knee joint inflammatory disease including Sjogren's syndrome

19. Has neuropathic knee osteoarthropathy, also known as Charcot joint

20. Has any medical condition that does not allow possible arthroscopy of the knee

21. Has neurological deficit (sensory, motor, or reflex)

22. Is currently involved in another investigation of the lower extremity

23. Anticipates having another lower extremity surgery during the study period

24. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)

25. Has received any corticosteroid knee injections = 3 months prior to surgery

26. Has chondrocalcinosis

27. Has proven osteoporosis

28. Is on immunostimulating or immunosuppressing agents

29. Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)

30. Is a female who is lactating, expecting, or is intending to become pregnant during the study period

31. Is an active smoker

32. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)

33. Is a prisoner

34. Has a condition or be in a situation that, in the Investigator's opinion, may confound the study results, or may interfere significantly with the subject's participation in the study

Related Conditions & MeSH terms

• Meniscectomy
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Trammpolin® meniscus prosthesis
Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht
Netherlands	Radboud UMC	Nijmegen
Netherlands	Sint Maartenskliniek	Ubbergen

Sponsors (1)

Lead Sponsor	Collaborator
ATRO Medical B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale	Performance of the Trammpolin® meniscus prosthesis in improving pain	24 Months
Primary	Trammpolin® meniscus prosthesis device related complications	The nature and frequency of all adverse events observed during the study	24 Months
Secondary	KOOS Pain sub-scale	KOOS Pain sub-scale	6 Weeks; 3, 6 and 12 Months
Secondary	Overall KOOS scale	Overall KOOS scale	6 Weeks; 3, 6, 12 and 24 Months
Secondary	Lysholm scale	Lysholm scale	6 Weeks; 3, 6, 12 and 24 Months
Secondary	IKDC objective scale	IKDC objective scale	6 Weeks; 3, 6, 12 and 24 Months
Secondary	Knee X-ray	Joint space measurement	6 Weeks; 12 and 24 Months
Secondary	Knee MRI	Cartilage damage and extrusion	12 and 24 Months